Over the past three years, Amgen has released an annual “Trends in Biosimilars Report.” And 2017 is no exception. In its fourth annual 50-page report, Amgen presents expert viewpoints from the U.S. reimbursement community, as well as information on current physician and patient perceptions and formulary considerations. For those who have a deep understanding of the biosimilar industry, this report likely won’t be your number-one source of information. Much of what I read was not altogether surprising or new. But, the report called attention to a few trends that align with what I’ve been observing within the industry that manufacturers, payers, and prescribers should expect for the year (and years) ahead.
1. Manufacturing Transparency: A New Competitive Angle?
What I’ve heard and read in many places is that manufacturing transparency is a priority for patients and physicians. Amgen's report this year continues to stress these demands.
In the report, one patient advocate, Seth Ginsberg, the president of the Global Healthy Living Foundation, writes, “If you want us (and our physicians) to be confident in our choice of biologic or biosimilar, we want…full transparency at the manufacturer level. We want to know who’s making the product, how it’s made, and what their track record is.”
But I’d argue a new age is dawning in which companies will turn manufacturing transparency into a branding method in an increasingly competitive field. As BioPharma-Reporter.com reported in an article last month, one biosimilar company even went so far as to emphasize the importance of the country in which a biosimilar is made. According to (unreleased) research performed by biosimilar pure-play Coherus, patients and physicians prefer biosimilars manufactured in the U.S. (It’s probably important to note that the CMO employed by Coherus has four facilities in the U.S.)
This claim was met with a lot of speculation in the industry, and many of the leading companies — for instance, Sandoz, which has no U.S. manufacturing facilities — argued quality, not location, is more important.
BioPharma-Reporter.com even launched its own survey asking whether American-made biosimilars would be more successful in the U.S. Out of 117 people, 70 percent believe manufacturing location will not make a biosimilar more successful. A second question asked if U.S. physicians and patients would care about where a biosimilar was made. Seventy-five percent of 118 respondents said, “No.”
While quality and a well-recognized brand name have always been key to building patient trust, I expect we’ll start seeing more companies put their own spin on manufacturing transparency, like Coherus did — especially as the market becomes more competitive.
2. Initiatives Against Non-Medical Switching On The Rise
Patients’ concerns about non-medical switching have been prominent over the past year or so. But I was struck by something else patient advocate Ginsberg mentioned in his statement.
“We aren’t willing to let financial and bureaucratic obstacles stand between us and the biologics we depend on,” he writes. “[Global Healthy Living Foundation] recently helped write a bill, adopted into law in New York State, which allows for an appeal process and accelerated approval pathway when an insurer requires a patient to obtain prior authorization or go through steps to get their meds. Prior to that legislation, patients and physicians had little recourse if insurance companies required a step-edit.”
The law he mentions was signed by the governor in December of 2016. Step therapy programs are often implemented by insurance plans to put patients on more cost-effective treatments prior to costly, newer, and riskier medications. As such, patients who are prescribed a high-cost treatment may be required to try other treatments and demonstrate they are not efficacious before receiving the higher-cost treatment. To avoid these “steps,” physicians must obtain authorization from the insurer.
As the U.S. biosimilar market takes shape, there has been a lot of discussion about how to bolster biosimilar use. And step therapy programs, which would require a patient to try the biosimilar before the more costly biologic, has been one such proposed method.
So, naturally, Ginsberg’s mention of bills to accelerate prior authorization caught my eye. The New York state law is not the only one of its kind implemented on the state level to improve or tweak the prior authorization process. Scanning the National Conference of State Legislatures webpage on prescription drug legislation turned up several other bills that are on various parts of the path toward enactment. For instance, Arkansas, California, Georgia, Hawaii, Missouri, Ohio, Oklahoma, and West Virginia (among others) have some form of legislation either pending or approved that will impact or accelerate step therapy and prior authorization protocols.
Legislation such as this opens the door for physicians to authorize the use of the reference product for biologics patients who are just starting out with a new insurance company. And even more broadly, this legislation takes away some of the tools health plans might put in place to increase the use of biosimilars. (Though we’ve also seen CVS and United Healthcare remove Neupogen altogether from their formularies, in turn eliminating the need for step therapy.) We’ll likely continue to see more of these laws challenging biosimilar uptake in the years ahead.
3. In The Age Of Oncology Biosimilars, Supply Chain Will Be Key
While the anti-TNF and G-CSF agents have faced regulators and, in some cases, have begun weathering the market, we’re only just seeing the approval of the first oncology monoclonal antibody (mAb) biosimilars. Truxima (Celltrion’s rituximab biosimilar) became the first oncology mAb to earn EU approval in December 2016. (In fact, the EMA now has five biosimilar rituximab applications up for review, along with four trastuzumab biosimilars and two bevacizumab biosimilars. The FDA has also received a few mAb biosimilar applications.)
There are a number of factors payers and those building formularies consider when selecting treatments, including the device, available dosages, and patient support programs. But as we enter the age of oncology biosimilars, manufacturer’s supply-chain reliability will be another big consideration. According to the Amgen report, shortages are particularly common in the oncology field. This leads to disruptions in therapy, and puts doctors in a position to determine which patients can be taken off the therapy earlier than planned. For instance, the results of a survey reveal that 98 percent of 358 surveyed directors of pharmacy faced a shortage that led to the use of alternative drugs or regimens, different drug doses, a delay in treatment, lapses in patient safety, or patient transfers to other facilities.
Just as patients will judge a brand based on its quality (and perhaps where it is manufactured), this report suggests supply-chain reliability will be another competitive factor. The size of the U.S. market is its own animal compared to some of the European markets. As such, a company’s success abroad will not necessarily translate to success in the U.S. without adequate supply-chain preparations.